Biomedical subjects

Pim de Feyter

Publications and source records attributed to Pim de Feyter.

At least 19 recordsLinked to original sources

PubMed2006

Meta-analysis of the studies assessing temporal changes in coronary plaque volume using intravascular ultrasound.

To assess the temporal effect of statin therapy on coronary atherosclerotic plaque volume measured by intravascular ultrasound (IVUS), we searched PubMed for eligible studies published between 1990 and January 2006. Inclusion criteria for retrieved studies were (1) IVUS volume analysis at baseline and follow-up and (2) statin therapy in > or =1 group of patients. All data of interest were abstracted in prespecified structured collection forms. Statistical analysis was performed with Review Manager 4.2. Random-effect weighted mean difference (WMD) was used as summary statistics for comparison of continuous variables. Nine studies of 985 patients (with 11 statin treatment arms) were selected. After a mean follow-up of 9.8 +/- 4.9 months, we found a significant decrease in coronary plaque volume (WMD -5.77 mm(3), 95% confidence interval -10.36 to -1.17, p = 0.01), with no significant heterogeneity across studies (p = 0.47). Prespecified subgroup analyses showed similar trends. Studies in which the achieved low-density lipoprotein (LDL) cholesterol level was <100 mg/dl showed a trend for plaque regression (WMD -7.88 mm(3), 95% confidence interval -16.31 to 0.55, p = 0.07), whereas studies in which the achieved level of LDL cholesterol was > or =100 mg/dl, the trend was less evident (WMD -4.22 mm(3), 95% confidence interval -10.27 to 1.82, p = 0.17). Plaque volume remained essentially unchanged in patients not treated with statins (WMD 0.13 mm(3), 95% confidence interval -4.42 to 4.68, p = 0.96). In conclusion, statin therapy, particularly when achieving the target LDL level, appears to promote a significant regression of coronary plaque volume as measured by IVUS.

Cholesterol, LDL↗

PubMed2006

Global characterization of coronary plaque rupture phenotype using three-vessel intravascular ultrasound radiofrequency data analysis.

AIMS: To compare the global characteristics of patients with and without evidence of plaque rupture (PR) in their coronary tree and to evaluate the phenotype of ruptured plaques using intravascular ultrasound (IVUS) radiofrequency data analysis (IVUS-VH). METHODS AND RESULTS: Forty patients underwent three-vessel IVUS-VH interrogation. Twenty-eight PRs were diagnosed in 26 vessels (25.7% of the vessels studied) of 20 patients (50% of the population). Ruptures located in the left anterior descending were clustered in the proximal part of the vessel, whereas ruptures located in the right coronary artery were more distally located (P=0.02). Patients with at least one PR presented larger body mass index (BMI) (28.4+/-3.7 vs. 25.8+/-2.6 kg/m(2), P=0.01) and plaque burden (40.7+/-7.6 vs. 33.7+/-8.4%, P=0.01) than patients without rupture, despite showing similar lumen cross-sectional area (9.6+/-3.3 vs. 9.2+/-2.3 mm(2), P=0.60). Among current smokers, 66.7% presented a PR in their coronary tree. Finally, PR sites showed a higher content of necrotic core compared with minimum lumen area sites (17.48+/-10.8 vs. 13.10+/-6.5%, P=0.03) and a trend towards higher calcified component. CONCLUSION: Patients with at least one PR in their coronary tree presented larger BMI and worse IVUS-derived characteristics compared with patients without PR.

Body Mass Index↗

PubMed2006

Distance from the ostium as an independent determinant of coronary plaque composition in vivo: an intravascular ultrasound study based radiofrequency data analysis in humans.

AIMS: Relative plaque composition, more than its morphology alone, is thought to play a pivotal role in determining propensity to vulnerability. Thus, we investigated in vivo whether the distance from coronary ostium to plaque location independently affects plaque composition in humans. This may help explaining the recently reported non-uniform distribution of culprit lesions along the vessel in acute coronary syndromes. METHODS AND RESULTS: In 51 consecutive patients (45 men), aged 38-76 years (mean age: 58+/-10), a non-culprit vessel was investigated through spectral analysis of IVUS radiofrequency data (IVUS-Virtual Histology). The study vessel was the left anterior descending artery in 23 (45%) patients; the circumflex artery in nine (18%), and right coronary artery in 19 (37%). The overall length of the region of interest, subsequently divided into 10 mm segments, was 41.5+/-13 mm long (range: 30.2-78.4). No significant change was observed in terms of relative plaque composition along the vessel with respect to fibrous, fibrolipidic, and calcified tissue, whereas the percentage of lipid core resulted to be increased in the first (median: 8.75%; IQR: 5.7-18) vs. the third (median: 6.1%; IQR: 3.2-12) (P=0.036) and fourth (median: 4.5%; IQR: 2.4-7.9) (P=0.006) segment. At multivariable regression analysis, distance from the ostium resulted to be an independent predictor of relative lipid content [beta=-0.28 (95%CI: -0.15, -0.41)], together with older age, unstable presentation, no use of statin, and presence of diabetes mellitus. CONCLUSION: Plaque distance from the coronary ostium, as an independent determinant of relative lipid content, is potentially associated to plaque vulnerability in humans.

Adult↗

PubMed2005

In vivo intravascular ultrasound-derived thin-cap fibroatheroma detection using ultrasound radiofrequency data analysis.

OBJECTIVES: The purpose of this study was to assess the prevalence of intravascular ultrasound (IVUS)-derived thin-cap fibroatheroma (IDTCFA) and its relationship with the clinical presentation using spectral analysis of IVUS radiofrequency data (IVUS-Virtual Histology [IVUS-VH]). BACKGROUND: Thin-cap fibroatheroma lesions are the most prevalent substrate of plaque rupture. METHODS: In 55 patients, a non-culprit, non-obstructive (<50%) lesion was investigated with IVUS-VH. We classified IDTCFA lesions as focal, necrotic core-rich (> or =10% of the cross-sectional area) plaques being in contact with the lumen; IDTCFA definition required a percent atheroma volume (PAV) > or =40%. RESULTS: Acute coronary syndrome (ACS) (n = 23) patients presented a significantly higher prevalence of IDTCFA than stable (n = 32) patients (3.0 [interquartile range (IQR) 0.0 to 5.0] vs. 1.0 [IQR 0.0 to 2.8], p = 0.018). No relation was found between patient's characteristics such as gender (p = 0.917), diabetes (p = 0.217), smoking (p = 0.904), hypercholesterolemia (p = 0.663), hypertension (p = 0.251), or family history of coronary heart disease (p = 0.136) and the presence of IDTCFA. A clear clustering pattern was seen along the coronaries, with 35 (35.4%), 31 (31.3%), 19 (19.2%), and 14 (14.1%) IDTCFAs in the first 10 mm, 11 to 20 mm, 21 to 30 mm, and > or =31 mm segments, respectively, p = 0.008. Finally, we compared the severity (mean PAV 56.9 +/- 7.4 vs. 54.8 +/- 6.0, p = 0.343) and the composition (mean percent necrotic core 19.7 +/- 4.1 vs. 18.1 +/- 3.0, p = 0.205) of IDTCFAs between stable and ACS patients, and no significant differences were found. CONCLUSIONS: In this in vivo study, IVUS-VH identified IDTCFA as a more prevalent finding in ACS than in stable angina patients.

Aged↗

PubMed2005

In-vivo, cardiac-cycle related intimal displacement of coronary plaques assessed by 3-D ECG-gated intravascular ultrasound: exploring its correlate with tissue deformability identified by palpography.

BACKGROUND: ECG-gated image acquisition of intravascular ultrasound (IVUS) has been shown to provide more accurate measurements at different phases of the cardiac cycle. OBJECTIVE: We sought to explore the ability dynamic assessment of ECG-gated 3-D IVUS to identify deformable regions of coronary plaques, by testing the hypothesis that at a given pressure and region, a faster displacement of the intima would correspond to high strain (soft tissue) regions assessed by palpography. METHODS: ECG-gated 3-D IVUS and palpograms were acquired using 30 and 20 MHz IVUS imaging catheters respectively. Frames with high and/or low strain spots identified by palpography were randomly selected and the spots were assigned to a respective quadrant within the cross section. A color-blinded side-by-side view was performed to enable the co-localization of the same region. Subsequently, the pressure driven displacement of the intima was established for each quadrant and a binary score (significant displacement or no displacement) was decided. RESULTS: One hundred and twenty-four quadrants were studied and the prevalence of highly deformable quadrants was low (n=7, 5.6% of the total). The sensitivity, specificity, positive predictive value and negative predictive value of 3-D ECG-gated IVUS to detect deformable quadrants as assessed by palpography were 42.9, 87.2, 16.7, and 96.2% respectively. CONCLUSION: In this pilot in vivo study, the intimal displacement velocity in the radial direction assessed by gray-scale 3-D ECG-gated IVUS failed to correlate with highly deformable regions. However, these preliminary findings suggest that the absence of significant displacement of the intima might be accurate to predict the absence of deformable tissue.

Contrast Media↗

PubMed2005

Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation.

OBJECTIVES: We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation. BACKGROUND: Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice. METHODS: The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES. RESULTS: In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST. CONCLUSIONS: The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.

Aged↗

PubMed2005

Long-term fluvastatin reduces the hazardous effect of renal impairment on four-year atherosclerotic outcomes (a LIPS substudy).

Mild renal impairment is an important risk factor for late cardiovascular complications. This substudy of the Lescol Intervention Prevention Study (LIPS) assessed the effect of fluvastatin on outcome of patients who had renal dysfunction and those who did not. Complete data for creatinine clearance calculation (Cockcroft-Gault formula) were available for 1,558 patients (92.9% of the LIPS population). Patients were randomized to fluvastatin or placebo after successful completion of a first percutaneous coronary intervention. Follow-up time was 3 to 4 years. The effect of baseline creatinine clearance on coronary atherosclerotic events (cardiac death, nonfatal myocardial infarction, and coronary reinterventions not related to restenosis) was evaluated. Baseline creatinine clearance (logarithmic transformation) was inversely associated with an incidence of adverse events among patients who received placebo (hazard ratio 0.99, 95% confidence interval 0.982 to 0.998, p = 0.01). However, no association was noted between creatinine clearance and the incidence of adverse events among patients who received fluvastatin (hazard ratio 1.0, 95% confidence interval 0.99 to 1.0, p = 0.63). No further deterioration in creatinine clearance was observed during follow-up, regardless of baseline renal function or allocated treatment. Occurrence of adverse events was not related to changes in renal function during follow-up. Fluvastatin therapy markedly decreased the risk of coronary atherosclerotic events after percutaneous intervention in patients who had lower values of creatinine clearance at baseline. The benefit of fluvastatin was unrelated to any effect on renal function.

Age Factors↗

PubMed2005

Impact of baseline renal function on mortality after percutaneous coronary intervention with sirolimus-eluting stents or bare metal stents.

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.

Aged↗

PubMed2005

Geometrical validation of intravascular ultrasound radiofrequency data analysis (Virtual Histology) acquired with a 30 MHz boston scientific corporation imaging catheter.

Recently, the plaque characterization field was explored with the use of the substrate (frequency domain analysis) rather than the envelope (amplitude or gray-scale imaging) of the intravascular ultrasound (IVUS) radiofrequency data. However, there is no data about the agreement of quantitative outcome between the two methods. The aim of this study was to assess the correlation and agreement between quantitative coronary ultrasound and the geometrical measurements provided by the spectral analysis of ultrasound radiofrequency data [IVUS-Virtual Histology (IVUS-VH), Volcano Therapeutics). Twenty-five patients were included in this study. The IVUS catheter used was a commercially available mechanical sector scanner (Ultracross 2.9 Fr 30 MHz catheter, Boston Scientific) covered with an outer sheath. IVUS-VH significantly underestimated lumen [relative difference (RD)=14.8+/-5.6; P<0.001], vessel (RD=14.1+/-4.8; P<0.001), and plaque (RD=11.5+/-10.8; P<0.001) cross-sectional areas (CSAs). Nevertheless, when adjusted for the ultrasound propagation delay caused by the sheath, relative differences of measurements were remarkably low (0.49%+/-6.3%, P=0.64 for lumen; 2.33%+/-4.6%, P=0.007 for vessel; and 4.2%+/-10.4%, P=0.005 for plaque CSA). These data suggest that the volumetric output of the IVUS-VH software underestimates measurements when acquired with a 30 MHz catheter. However, after applying a mathematical adjustment method for the ultrasound propagation delay caused by the outer sheath of the 30 MHz catheter, relative differences of direct measurements were negligible. These results suggest that ultrasound radiofrequency data analysis could provide, aside from precise compositional data, an accurate geometrical output.

Cardiac Catheterization↗

PubMed2005

Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology.

Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

Adult↗

PubMed2005

Fluvastatin reduces the impact of diabetes on long-term outcome after coronary intervention--a Lescol Intervention Prevention Study (LIPS) substudy.

BACKGROUND: Diabetes increases the risk of developing cardiovascular disease. Patients with diabetes undergoing percutaneous coronary intervention (PCI) show poorer outcomes compared with nondiabetic patients. The aim of this study was to determine the clinical benefit of long-term fluvastatin in patients with diabetes who had undergone a successful PCI. METHODS: This subanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial of patients who had undergone PCI and were treated with fluvastatin determined the impact of fluvastatin on the survival-free period of major adverse cardiac events (MACE) (defined as cardiac death, nonfatal myocardial infarction, and reintervention procedure [coronary artery bypass grafting, repeat PCI, PCI for a new lesion]). Patients with baseline total cholesterol levels of 135 to 270 mg/dL (3.5-7.0 mmol/L) and triglyceride levels of 400 mg/dL (4.5 mmol/L) were randomized at discharge either to fluvastatin (n = 844) or to placebo (n = 833); follow-up was 3 to 4 years. Among these patients, there were 202 with diabetes (120 on fluvastatin, 82 placebo) and 1475 without diabetes (724 on fluvastatin, 751 on placebo). The primary clinical outcome was survival time free of MACE and MACE excluding restenosis. RESULTS: The presence of diabetes increased the risk of MACE by almost 2-fold in placebo-treated patients (RR 1.78, 95% CI 1.20-2,64, P = .0045). In contrast, in diabetic patients treated with fluvastatin, the risk of MACE was not significantly different from that in patients without diabetes. Fluvastatin reduced the risk of MACE in diabetic patients by 51% (P = .0088). CONCLUSIONS: Diabetes is a consistent clinical predictor of cardiovascular complications and fluvastatin reduces the increased incidence of long-term adverse complications associated with the presence of diabetes.

Angioplasty, Balloon, Coronary↗

PubMed2005

Paclitaxel eluting stents for the treatment of angiographically non-significant atherosclerotic lesions.

OBJECTIVE: To assess the safety and efficacy of the implantation of Paclitaxel Eluting Stents (PES) for de novo, non-flow limiting lesions. METHODS AND RESULTS: We assessed the 12-month occurrence of major adverse cardiac events (MACE) in 21 patients (4% of the total population treated in a 'real world' registry) with 22 non-significant coronary narrowings treated with PES. The following criteria had to be met: (1) the lesion was de novo; (2) the location was non-ostial, and not a bifurcation lesion; (3) the diameter stenosis by quantitative coronary angiography (QCA) was <50%; (4) there was no visible thrombus and (5) the lesion was not located in an angiographically diffusely diseased segment. Procedural success rate was 100% without any periprocedural myocardial infarction. After a mean follow-up of 407.33+/-53 (range: 344-498) days the overall MACE-free survival was 95.2%. Freedom from target revascularization was 95.2%. CONCLUSIONS: The result of this non-randomized observational study suggests that the implantation of PES for de novo, non-significant lesions appears most probably safe and effective.

Aged↗

PubMed2005

Sirolimus-eluting stents for the treatment of atherosclerotic ostial lesions.

BACKGROUND: Ostial atherosclerotic lesions are distinct from other lesion sites in terms of outcomes following percutaneous interventions. Despite aggressive lesion modification strategies, long-term outcome is hampered by restenosis. Various stent designs have failed to show significant improvement in target lesion revascularization (TLR) rates. The present study evaluates the clinical outcomes following sirolimus-eluting stent implantation for ostial lesions. MATERIALS AND METHODS: The sirolimus-eluting stent (SES) was the device of choice at our institute for all coronary interventions from April 2002 to March 2003. This study population is comprised of 50 patients who received drug-eluting stents for atherosclerotic ostial lesions during this period. Sixty-eight percent of the patients were male and 24 patients (48%) had a history of previous revascularization. Indication for intervention were as follows: acute myocardial infarction, 7 patients (14%), stable angina, 23 patients (46%), unstable angina, 20 patients (40%). Angioplasty and stent implantations were done according to the standard protocol. All patients were prospectively followed up for major adverse cardiac events. The event-free survival was 90% at one year. There were 5 (10%) target vessel revascularization, 3 (6%) myocardial infarctions and 1 (2%) death during a mean follow-up of 414.5 +/- 54.5 days. TLR was required in 4 (8%) patients. CONCLUSIONS: SES implantation is feasible in ostial locations and is associated with low subsequent revascularization.

Adult↗

PubMed2005

The efficacy of sirolimus-eluting stents versus bare metal stents for diabetic patients undergoing elective percutaneous coronary intervention.

BACKGROUND: Diabetes mellitus is a well-known risk factor for future adverse cardiac events after coronary intervention with conventional metal stents. In this study, the impact of sirolimus-eluting stents (SES) were evaluated in a consecutive group of diabetic patients undergoing elective percutaneous coronary treatment and compared to a population treated with bare metal stents. METHODS AND RESULTS: From April 2002, a policy of routine SES implantation has been instituted in our hospital. During 1 year of enrollment, a total of 112 consecutive diabetic patients with de novo coronary lesions were electively treated with SES (SES group). A similar group for comparison comprised 118 consecutive patients treated with bare metal stents in the preceding period (the pre-SES group). After 1-year follow-up, the cumulative rate of major adverse cardiac events (death, myocardial infarction, and any repeat revascularization) was 17.3% in the SES group versus 30.2% in the pre-SES group (hazard ratio, 0.54 [95% confidence interval, 0.32-0.91]; p = 0.02), mainly due to a marked reduction in the need for repeat revascularization (10.2% versus 23.5%; hazard ratio, 0.40 [95% confidence interval, 0.21-0.78]; p = 0.007). CONCLUSIONS: Routine utilization of SES for diabetic patients significantly reduces the rate of adverse cardiac events at 1 year compared to bare metal stents.

Aged↗

PubMed2005

One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries.

BACKGROUND: The efficacy of sirolimus-eluting stents (SES) compared to paclitaxel-eluting stents (PES) remains unknown. We evaluated the clinical outcomes after implantation of 2.25 mm diameter SES and PES. METHODS AND RESULTS: PES have been used as the stent of choice for all percutaneous coronary interventions as part of the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry. Ninety consecutive patients received at least one 2.25 mm PES (PES group), and were compared with 107 patients who received at least one 2.25 mm SES as part of the RESEARCH registry. The overall population presented high-risk characteristics commonly excluded from most studies. Populations were well-matched. There were 2 (2.2%) incidents of subacute stent thrombosis in the PES group (in a 2.25 mm stent), and none in the SES group. At one year, the cumulative incidence of major adverse cardiac events was 5.6% in the SES group, and 17.8% in the PES group (p = 0.007). After adjustments for other significant univariate variables, presentation with acute coronary syndrome (ACS) (adjusted OR 5.2 [95% CI 1.8-15.0], p = 0.002) and PES utilization (adjusted OR 3.7 [95% CI 1.3-10.5], p = 0.013) were found to be significant independent predictors of major adverse cardiac events (MACE). CONCLUSIONS: In an unselected population treated for very small vessel disease, SES were associated with better 12-month clinical outcomes and the use of PES was identified as an independent predictor of adverse events.

Angioplasty, Balloon, Coronary↗

PubMed2004

Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial.

OBJECTIVES: We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary lesions. BACKGROUND: Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. METHODS: The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 microg/cm(2) of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. RESULTS: The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. CONCLUSIONS: The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Aged↗

PubMed2004

Effectiveness of sirolimus-eluting stent implantation for the treatment of coronary artery disease in octogenarians.

Sirolimus-eluting stent (SES) implantation has been shown to reduce repeat revascularization in various randomized trials. The present study evaluated the outcomes after SES implantation in 46 octogenarian patients. SES implantation in octogenarians appears to be feasible and is associated with very small subsequent need for repeat target vessel revascularization at 1 year.

Aged↗

PubMed2004

Effectiveness of sirolimus-Eluting stent implantation for coronary narrowings <50% in diameter.

The long-term efficacy of percutaneous coronary intervention for mildly obstructive coronary narrowings is limited by the occurrence of restenosis, limiting the applicability of this therapy for these lesions. The present study reports on a consecutive series of 20 patients treated with sirolimus-eluting stent implantation for 23 angiographically mild de novo lesions (defined as a diameter stenosis <50% by quantitative coronary angiography). At a mean follow-up of 399 +/- 120 days, the survival-free of major adverse events was 95%, with no patient requiring target lesion revascularization.

Coronary Angiography↗